CYCLOSPORINE - Generic Drug Details

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What are the generic sources for cyclosporine and what is the scope of patent protection?

Cyclosporine is the generic ingredient in nine branded drugs marketed by Apotex, Dr Reddys Labs Sa, Ivax Sub Teva Pharms, Sandoz, Strides Pharma, Abbvie, Novartis, Deva Holding As, Mylan, Saptalis Pharms, Teva Pharms Usa Inc, Harrow Eye, Hikma, Padagis Us, Sun Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in twenty-eight NDAs. There are twenty-seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cyclosporine has two hundred and ninety-nine patent family members in thirty-three countries.

There are eighteen drug master file entries for cyclosporine. Nineteen suppliers are listed for this compound.

Summary for CYCLOSPORINE

International Patents:	299
US Patents:	27
Tradenames:	9
Applicants:	17
NDAs:	28
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	1,059
Patent Applications:	7,363
Drug Prices:	Drug price trends for CYCLOSPORINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CYCLOSPORINE
What excipients (inactive ingredients) are in CYCLOSPORINE?	CYCLOSPORINE excipients list
DailyMed Link:	CYCLOSPORINE at DailyMed

See drug prices for CYCLOSPORINE

Recent Clinical Trials for CYCLOSPORINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fred Hutchinson Cancer Center	Phase 2
National Cord Blood Network	Phase 2
Assiut University	Phase 1

See all CYCLOSPORINE clinical trials

Pharmacology for CYCLOSPORINE

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for CYCLOSPORINE

Antifungal Agents
Antirheumatic Agents
Calcineurin Inhibitors
Dermatologic Agents
Enzyme Inhibitors
Immunosuppressive Agents

Paragraph IV (Patent) Challenges for CYCLOSPORINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RESTASIS MULTIDOSE	Ophthalmic Emulsion	cyclosporine	0.05%	050790	1	2014-01-13

US Patents and Regulatory Information for CYCLOSPORINE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ivax Sub Teva Pharms	CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	065110-002	Mar 29, 2005	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913-001	Aug 14, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Ivax Sub Teva Pharms	CYCLOSPORINE	cyclosporine	CAPSULE;ORAL	065110-001	Mar 29, 2005	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for CYCLOSPORINE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	RESTASIS	cyclosporine	EMULSION;OPHTHALMIC	050790-001	Dec 23, 2002	⤷ Sign Up	⤷ Sign Up
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995	⤷ Sign Up	⤷ Sign Up
Novartis	NEORAL	cyclosporine	CAPSULE;ORAL	050715-003	Jul 14, 1995	⤷ Sign Up	⤷ Sign Up
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016	⤷ Sign Up	⤷ Sign Up
Novartis	NEORAL	cyclosporine	SOLUTION;ORAL	050716-001	Jul 14, 1995	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for CYCLOSPORINE

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1891939	Compositions comprenant des composés ammonium quaternaires (Compositions containing quaternary ammonium compounds)	⤷ Sign Up
South Korea	20160097369	디스펜서용 보호 캡 및 제약용 및/또는 화장용 액체(cosmetic liquids)를 방출하기 위한 방출장치 (PROTECTIVE CAP FOR A DISPENSER, AND DISCHARGE DEVICE FOR DISCHARGING PHARMACEUTICAL AND/OR COSMETICAL LIQUIDS)	⤷ Sign Up
South Africa	200703751	Ophthalmic oil-in-water type emulsion with stable positive zeta potential	⤷ Sign Up
Israel	246121	מכסה מגן עבור מחלק מנות, והתקן פריקה לפריקת נוזלים תרופתיים ו/או קוסמטיים (Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids)	⤷ Sign Up
European Patent Office	4218729	FORMULATIONS TOPIQUES ET LEURS UTILISATIONS (TOPICAL FORMULATIONS AND USES THEREOF)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CYCLOSPORINE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1809237	C01809237/01	Switzerland	⤷ Sign Up	PRODUCT NAME: CICLOSPORIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66093 08.09.2016
1809237	122015000043	Germany	⤷ Sign Up	PRODUCT NAME: OPHTHALMISCHE EMULSION ENTHALTEND CYCLOSPORIN; REGISTRATION NO/DATE: EU/1/15/990 20150319
1809237	CR 2015 00030	Denmark	⤷ Sign Up	PRODUCT NAME: CYCLOSPORIN; REG. NO/DATE: EU/1/15/990/001-002 20150323
2049079	LUC00006	Luxembourg	⤷ Sign Up	PRODUCT NAME: CYCLOSPORINE (GOUTTES OCULAIRES SOUS FORME D'EMULSION); AUTHORISATION NUMBER AND DATE: EU/1/15/990 20150323
2049079	PA2017003,C2049079	Lithuania	⤷ Sign Up	PRODUCT NAME: CIKLOSPORINAS; REGISTRATION NO/DATE: EU/1/15/990 20170319
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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